Clinical QA Manager

4 weeks ago


New York, United States PSG Global Solutions Full time

Description We're looking for a

Clinical QA Manager , working in

Pharmaceuticals

and

Medical Products

industry in

155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States .

Job description:

Chairs the Regulatory Authority Facilitation Team, and ensures that company clinical facility and clinical sites are prepared for clinical inspections and the inspections are successfully facilitated. Writes Inspection Readiness Plans as necessary. Facilitates sponsor and site inspections as necessary. Manages the Clinical Document Audit function, and plans, prepares, performs, and reports on CQA audits of Clinical Study Reports and Trial Master Files. Develops Study Audit Plans and prepares, performs, and reports on CQA audits of investigator sites. Plans, prepares, performs, and reports on CQA audits of internal processes. Provides GCP and Lessons Learned training.

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